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NOT YET RECRUITING
NCT07739407
NA

Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation

Sponsor: ferdi gülaştı

View on ClinicalTrials.gov

Summary

This single-center, prospective, randomized, controlled clinical trial aims to evaluate whether ultrasound-guided PECS II block, when added to standard local infiltration anesthesia, improves perioperative analgesia in patients undergoing elective permanent pacemaker implantation. Seventy-two adult patients scheduled for elective permanent pacemaker implantation will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided PECS II block plus standard local infiltration anesthesia or standard local infiltration anesthesia alone. The primary outcome is pain intensity during pacemaker pocket creation measured using the Numerical Rating Scale (NRS). Secondary outcomes include intraoperative pain scores, additional local anesthetic, opioid and sedative requirements, postoperative pain scores, analgesic consumption during the first 24 hours, patient and operator satisfaction, procedure duration, and procedure-related complications. The study is designed to determine whether PECS II block provides additional analgesic benefit during permanent pacemaker implantation.

Official title: The Contribution of Ultrasound-Guided PECS II Block to Standard Local Infiltration Anesthesia During Elective Permanent Pacemaker Implantation: A Prospective Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2026-08-05

Completion Date

2027-08-05

Last Updated

2026-07-31

Healthy Volunteers

No

Interventions

OTHER

Ultrasound-Guided PECS II Block

Ultrasound-guided PECS II block will be performed before permanent pacemaker implantation using 20 mL of 0.25% bupivacaine. The local anesthetic will be injected between the pectoralis major and pectoralis minor muscles and between the pectoralis minor and serratus anterior muscles under ultrasound guidance.

OTHER

Standard Local Infiltration Anesthesia

Standard local infiltration anesthesia will be administered by the implanting physician using 1% lidocaine at the incision site and pacemaker pocket according to routine clinical practice.